Cleared Special

Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags (K191335) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K191335 · Corinth Medtech, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2019
Decision
20d
Days
Class 2
Risk

K191335 is an FDA 510(k) clearance for the Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, V.... Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by Corinth Medtech, Inc. (Cupertino, US). The FDA issued a Cleared decision on June 6, 2019 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1690 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Corinth Medtech, Inc. devices

Submission Details

510(k) Number K191335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2019
Decision Date June 06, 2019
Days to Decision 20 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
140d faster than avg
Panel avg: 160d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HIH Hysteroscope (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1690
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HIH Hysteroscope (and Accessories)

All 93
Devices cleared under the same product code (HIH) and FDA review panel - the closest regulatory comparables to K191335.
Aveta System
K191958 · Meditrina, Inc. · Oct 2019
Omni Hysteroscope, Omni Lok cervical seal
K191281 · Hologic, Inc. · Aug 2019
Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid
K190827 · Uvision360, Inc. · Jun 2019
MAKO 7
K182975 · Boston Scientific Corporation · May 2019
Aveta System
K190372 · Meditrina, Inc. · May 2019
Endosee System
K190639 · CooperSurgical, Inc. · May 2019